MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMORAL CR IMPACTOR PAD; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a left knee procedure the impactor fractured during use.No harm or delay occurred.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified exhibit signs of repeated use (nicked or gouged) and confirming complaint is fractured.Review of the device history record identified no deviations or anomalies during manufacturing.Device has a potential field age of 9 years and exhibits signs of repeated use.The root cause of the reported event is attributed to wear and tear of the device from repeated use over time.The reported event is unconfirmed with the return of the device.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h6, and h11.

Event Description

No further event information is available at the time of this report.

• Brand Name: PERSONA FEMORAL CR IMPACTOR PAD
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19188795
• MDR Text Key: 341141292
• Report Number: 0001822565-2024-01416
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024232891
• UDI-Public: (01)00889024232891(10)62788671
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42509909400
• Device Lot Number: 62788671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/25/2024
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1